Biotechnological Drugs: Pharmaco-Toxicological Aspects and Pharmaceutical Regulatory Affairs and Patents
A.Y. 2024/2025
Learning objectives
The purpose of the course is to introduce the students to the pharmacology (pharmacokinetics, toxicity and pharmacodynamics), the relevant European Community legislation concerning Marketing Authorization (MA) and patents of new biotechnological medicinal products, including biosimilars.
Expected learning outcomes
The student will acquire the knowledges needed to understand how monoclonal antibodies (and biosimilars) work, how they can be used in the treatment of several pathologies, how to evaluate their toxicological profile and the legislative aspects and patents.
Lesson period: Second semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
Second semester
Prerequisites for admission
Students are required to attend and pass the exam of Pharmacology and Pharmacotherapy before attending the present course.
Assessment methods and Criteria
Students will prepare and present orally (groups of 2-4 students, PowerPoint file, 10 min max each) a research on one of the antibodies, either presented during the lessons or chosen by the students, covering different aspects: pharmacology, toxicology, therapeutics, legislation, and pharmaceutical technique. The final grade will be for both courses (Prof Minghetti and Prof Bellosta)
The final grade will be calculated as:
50% oral presentation
20% attendance to lessons (at least 75%)
30% reply to questions on the topics of the two courses
The final grade will be calculated as:
50% oral presentation
20% attendance to lessons (at least 75%)
30% reply to questions on the topics of the two courses
Biotechnological drugs: pharmaco-toxicological aspects
Course syllabus
Biotechnological drugs
Characteristics of monoclonal antibodies
Pharmaco-toxicology of biotechnological drugs
Monoclonal antibodies used in autoimmune diseases
Anti-inflammatory monoclonal antibodies
Monoclonal antibodies in oncology
Monoclonal antibodies against angiogenesis
Use and safety of monoclonal antibodies
Characteristics of monoclonal antibodies
Pharmaco-toxicology of biotechnological drugs
Monoclonal antibodies used in autoimmune diseases
Anti-inflammatory monoclonal antibodies
Monoclonal antibodies in oncology
Monoclonal antibodies against angiogenesis
Use and safety of monoclonal antibodies
Teaching methods
Oral lessons in class. If necessary, lessons will be via Teams.
Teaching Resources
All the slides presented at the course and the recording of the lessons will be published on the Ariel website.
Pharmaceutical Regulatory Affairs and Patents
Course syllabus
Procedures for obtaining the Marketing Authorisation.
The Common Technical Document (CTD) and description of modules 3, 4, and 5.
European public assessment reports (EPARs)
Supplementary Protection Certificate (SPC).
Biotechnological medicinal products. Biosimilars.
Patents.
Aspects of marketing and merchandising: medicinal products' supply chain.
Healthcare issues. The price of medicinal products and pharmacoeconomic issues.
The Common Technical Document (CTD) and description of modules 3, 4, and 5.
European public assessment reports (EPARs)
Supplementary Protection Certificate (SPC).
Biotechnological medicinal products. Biosimilars.
Patents.
Aspects of marketing and merchandising: medicinal products' supply chain.
Healthcare issues. The price of medicinal products and pharmacoeconomic issues.
Teaching methods
Oral lessons. If necessary, lessons will be via Teams.
Teaching Resources
Lessons slides and additional material are available on the ARIEL website.
Biotechnological drugs: pharmaco-toxicological aspects
BIO/14 - PHARMACOLOGY - University credits: 4
Lessons: 32 hours
Pharmaceutical Regulatory Affairs and Patents
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours